Application 078964

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	TABLET, DELAYED RELEASE;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078964-001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB		2013-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078964-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A078964-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078964-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078964-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078964-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078964-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078964-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078964-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078964-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078964-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078964-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078964-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078964-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078964-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078964-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078964-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078964-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078964-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078964-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078964-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078964-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078964-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078964-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078964-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078964-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078964-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078964-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078964-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078964-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078964-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078964-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078964-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078964-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078964-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078964-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078964-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078964-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078964-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078964-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078964-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078964-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078964-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078964-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078964-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078964-001	AB	1	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Ascend Laboratories, LLC	45092108-7c4a-48f9-8222-ca8612e82189	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: Rabeprazole Sodium generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals Inc.	4582d443-f1be-4f94-85da-49aa603f54e4	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: RABEPRAZOLE SODIUM generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals, Inc.	ac9266ed-a9b2-4e77-8607-393b5dcdd2b6	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: Rabeprazole Sodium generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	REMEDYREPACK INC.	0e2e00fa-c4c5-4de7-adf9-cd9786b97016	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: RABEPRAZOLE SODIUM generic name: RABEPRAZOLE SODIUM
Rabeprazole sodium	RABEPRAZOLE SODIUM	Torrent Pharmaceuticals Limited	04e88b86-e1dd-4c56-8359-45fbcc161f7d	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Rabeprazole sodium generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	St. Mary's Medical Park Pharmacy	9237eaa4-8eec-fb2a-e053-2995a90ab6c0	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Rabeprazole Sodium generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	St. Mary's Medical Park Pharmacy	c212c9d5-32d3-3c5f-e053-2a95a90af88b	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: RABEPRAZOLE SODIUM generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	4e8b9858-23a1-4363-b26f-ee6b9ff7ebf9	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: RABEPRAZOLE SODIUM generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	68b7a793-f22b-4609-a640-94fdec703d93	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Rabeprazole Sodium generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium DR	RABEPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	bdad0b58-495e-2352-e053-2a95a90a3198	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium DR	RABEPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	b354053c-cb83-79c6-e053-2a95a90afdbe	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	350c20b0-1879-d4cb-e063-6294a90a37f2	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: RABEPRAZOLE SODIUM generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Asclemed USA, Inc.	3b6a25c2-fb61-4c86-9988-c6ffac7939c4	2026-02-14	Warnings, Adverse reactions	Name fallback brand name: Rabeprazole Sodium generic name: RABEPRAZOLE SODIUM
Aciphex	RABEPRAZOLE SODIUM	Waylis Therapeutics LLC	1eb38279-0237-4967-be7a-c53a826c1138	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Advagen Pharma Limited	b1a12c83-74ab-febc-e053-2a95a90a1441	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: RABEPRAZOLE SODIUM generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Chartwell RX, LLC	c5c43222-d167-4152-b5c7-84b55920a7ce	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Rabeprazole Sodium generic name: RABEPRAZOLE SODIUM
Rabeprazole sodium	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals Inc.	1855ccab-c377-4962-9225-3c5adc62e2bd	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: Rabeprazole sodium generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	PHOENIX RX LLC	3a674849-b2f6-5f43-e063-6294a90a9e20	2025-07-21	Warnings, Adverse reactions	Name fallback brand name: Rabeprazole Sodium generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	b1b7def0-834f-37f5-e053-2a95a90ade1f	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: RABEPRAZOLE SODIUM generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	0863f340-4c7e-379a-e063-6394a90a758d	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: RABEPRAZOLE SODIUM generic name: RABEPRAZOLE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-802	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	medsource pharmaceuticals	ANDA	Current
50090-1424	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	A-S Medication Solutions	ANDA	Current
63187-788	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Proficient Rx LP	ANDA	Current
63187-788	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Proficient Rx LP	ANDA	Current
68180-220	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-220	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-220	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-220	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-220	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-6864	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6864	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0656	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	REMEDYREPACK INC.	ANDA	Current
70518-0656	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	REMEDYREPACK INC.	ANDA	Current
70518-0656	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	REMEDYREPACK INC.	ANDA	Current
70518-0656	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	REMEDYREPACK INC.	ANDA	Current
71335-0027	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0027	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0027	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0027	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	ANDA	Current
71335-0027	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18490	ORIG	2013-11-19
9205	ORIG	2013-11-12